%0 Journal Article
%A Marín-Candón, Alicia
%A Rosso-Fernández, Clara M
%A Bustos de Godoy, Natalia
%A López-Cerero, Lorena
%A Gutiérrez-Gutiérrez, Belén
%A López-Cortés, Luis Eduardo
%A Barrera Pulido, Lydia
%A Borreguero Borreguero, Irene
%A León, María José
%A Merino, Vicente
%A Camean-Fernández, Manuel
%A Retamar, Pilar
%A Salamanca, Elena
%A Pascual, Alvaro
%A Rodriguez-Baño, Jesús
%A ASTARTÉ Study Group
%T Temocillin versus meropenem for the targeted treatment of bacteraemia due to third-generation cephalosporin-resistant Enterobacterales (ASTARTÉ): protocol for a randomised, pragmatic trial.
%D 2021
%U https://hdl.handle.net/10668/27611
%X Alternatives to carbapenems are needed in the treatment of third-generation cephalosporin-resistant Enterobacterales (3GCR-E). Temocillin is a suitable candidate, but comparative randomised studies are lacking. The objective is to investigate if temocillin is non-inferior to carbapenems in the targeted treatment of bacteraemia due to 3GCR-E. Multicentre, open-label, randomised, controlled, pragmatic phase 3 trial. Patients with bacteraemia due to 3GCR-E will be randomised to receive intravenously temocillin (2 g three times a day) or carbapenem (meropenem 1 g three times a day or ertapenem 1 g once daily). The primary endpoint will be clinical success 7-10 days after end of treatment with no recurrence or death at day 28. Adverse events will be collected; serum levels of temocillin will be investigated in a subset of patients. For a 10% non-inferiority margin, 334 patients will be included (167 in each study arm). For the primary analysis, the absolute difference with one-sided 95% CI in the proportion of patients reaching the primary endpoint will be compared in the modified intention-to-treat population. The study started after approval of the Spanish Regulatory Agency and the reference institutional review board. Data will be published in peer-reviewed journals. NCT04478721.
%K bacteriology
%K clinical pharmacology
%K infection control
%K infectious diseases
%K microbiology
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